ACES: A Cytel White Paper by Eric Silva

In the past decade, there has been a significant increase in the use of Data Monitoring Committees (DMC) and Adaptive Designs (AD) in clinical trials. While the monitoring of safetydata by a formal committee is not required for all clinical trials, it has become the norm to have a formal DMC conduct periodic safety reviews for any controlled trial that evaluates treatments intended to prolong life or reduce risk of major adverse health outcomes, or for trials that compare rates of mortality or major morbidity.